A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to compare the immunogenicity of different dose schedules of the vaccine.

Blood samples were obtained for safety labs on Days 0, 7, 14, 90, 97, 104 and measurement of viremia at baseline [during the screening period or on day of vaccination (Day 0)], and then on Days 7, 9, 11, 14, 17, 21, 90, 97, and 104. Blood samples for measurement of dengue neutralizing antibodies in serum were obtained at baseline [during the screening period or on day of vaccination (Day 0)], then on Days 30, 90 and 120.

The entire duration for each individual subjects participation was approximately 5 months including recruitment and collection of data for primary outcomes (through Day 120).

Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported [ Time Frame: Day 0 to Day 104 ] [ Designated as safety issue: Yes ]

Erythema and Edema Were Graded Per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Where Grade 0=none to Grade 4=Severe. Pain and Itching were graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where Grade 0=no pain or itching to Grade 4= Life-threatening/severe. Only those score categories for which there was at least 1 participant are reported.

Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose [ Time Frame: For 30 days after each dose (Up to Day 120) ] [ Designated as safety issue: Yes ]

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.

Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose [ Time Frame: For 30 days after each dose (Up to Day 120) ] [ Designated as safety issue: Yes ]

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Some AEs are automatically considered related because of temporal relationship to vaccination.

Rate of Seroconversion to Each of Four Dengue Serotypes [ Time Frame: Up to 30 days after the last immunization (Up to Day 120) ] [ Designated as safety issue: Yes ]

Rate of seroconversion was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plagues (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.

Secondary Outcome Measures:

Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations [ Time Frame: various timepoints up to 30 days after each dose (Up to Day 120) ] [ Designated as safety issue: Yes ]

Serotype-Specific TDV Viral RNA was assessed for the four dengue serotypes: Dengue-1, Dengue-2, Dengue-3 and Dengue-4 . Only those serotypes and time-points where at least 1 participant had Serotype-Specific TDV Viral RNA Detected is reported.

Any condition which would limit the subject's ability to complete the study in the opinion of the Investigator

Clinically significant ECG findings

History of any significant dermatologic disease in the last 6 months,

History of diabetes mellitus

History of recurring headaches or migraines (more frequent than once per week) or on prescription medication for treatment of recurring headaches or migraines

Hypersensitivity to any vaccine

Receipt of any vaccine in the 4 weeks preceding the first vaccination

Planned receipt of any vaccine in the 4 weeks following each of the vaccinations in this study

Known history of Japanese Encephalitis Virus (JEV) and/or Yellow Fever (YF)

Previous vaccination (in a clinical trial or with an approved product) against flaviviruses including dengue, yellow fever (YF) and Japanese Encephalitis (JE)

Seropositivity to dengue or West Nile (WN) virus

Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months

Use within the previous 6 months of systemic corticosteroids therapy (at a dose of at least 0.5 mg/kg/day). Topical prednisone is not permitted if currently in use or within the last 3 months. Note, inhaled prednisone (or equivalent) is allowed

Use of any non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen or antihistamines for the 3 days immediately prior to each vaccination

Use of any prescription or over the counter medications (besides those specifically mentioned above or those required for medical management of concurrent diseases) 7 days before the first vaccination (Day 0)

Donation of blood 6 weeks before the first dose(s) (Day 0) until 30 days after the dose on day 90

Females who are pregnant or lactating

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01542632